EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 5)
PB 47 of 2017
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Purpose
This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5) (the Amending Instrument). The purpose of the Amending Instrument is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) program.
The amendment made by this Instrument reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 47 of 2017 include the addition of a new brand of a pharmaceutical item, the deletion of two pharmaceutical items and changes to the circumstances for prescribing for two pharmaceutical items.
These changes are summarised, by drug name, in the Attachment.
A provision by provision Description of this instrument is contained in the Attachment.
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS. This includes consultation through the PBAC process. Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 July 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5)
PART 1 PRELIMINARY
Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5). It can also be cited as PB 47 of 2017.
Section 2 Commencement
This section provides that this instrument commences on 1 July 2017.
Section 3 Amendment
This section provides that the Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
SCHEDULE
Items 1 to 3 Schedule 1 and Schedule 3
Items 1 to 3 provide for the addition of a new brand of a pharmaceutical item, the deletion of two pharmaceutical items and changes to the circumstances for prescribing for two pharmaceutical items. A pharmaceutical item is a listed drug in a specified form, with a specified manner of administration.
Listed Drug | Type of Change |
Azacitidine | New brand added |
Epoprostenol | Two pharmaceutical items deleted, restrictions remodelled for two other pharmaceutical items |
Overview
The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, made under the National Health Act 1953, to update the Highly Specialised Drugs (HSD) program. Enacted by the Parliament of Australia, this amendment aims to align the HSD program with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The objective is to ensure that the HSD program continues to reflect current medical practices and evidence-based recommendations, thereby maintaining the availability and accessibility of highly specialised drugs to those in need. The amendments, which include adding a new brand of pharmaceutical item, deleting two pharmaceutical items, and altering prescribing conditions for two others, were developed in consultation with the Pharmaceutical Benefits Advisory Committee, ensuring recommendations are based on clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 5) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This Instrument applies to the Highly Specialised Drugs (HSD) Program under the National Health Act 1953, which is administered at the Commonwealth level. The amendments pertain specifically to the pharmaceutical items covered under the HSD Program, including the addition of a new brand, deletion of two items, and changes to prescribing conditions for two other items. These changes are designed to align with amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Instrument is applicable to pharmaceutical companies, healthcare providers, and patients who are part of the HSD Program, ensuring they are aware of the updates and modifications to the listed drugs and their associated conditions. The amendments are effective from 1 July 2017 and are a legislative instrument under the Legislation Act 2003.
Key Provisions
The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 5) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (referred to as the Special Arrangement). The purpose of this amendment is to update the Highly Specialised Drugs (HSD) program, aligning it with changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These amendments include the addition of a new brand of a pharmaceutical item, the deletion of two pharmaceutical items, and changes to the prescribing circumstances for two pharmaceutical items. These changes are detailed in the Attachment and are effective from 1 July 2017.
The Amending Instrument imposes specific obligations on the parties involved in the HSD program, primarily focusing on the compliance with the updated listings and conditions of pharmaceutical items. The Minister, through this Instrument, exercises the power to make special arrangements for the supply of pharmaceutical benefits, as outlined in subsection 100(1) of the National Health Act 1953. The obligations under this Instrument require adherence to the new amendments detailed in the Schedule, ensuring that the supply and prescription of pharmaceutical items align with the updated criteria and restrictions. Additionally, pharmaceutical companies and prescribing entities must ensure their practices comply with these new specifications to remain within the legal framework of the HSD program.
The Instrument also stipulates various consequences for non-compliance with its provisions. While specific offences and penalties are not detailed within the text of the Instrument, it is clear that failure to comply with the updated Special Arrangement could lead to legal repercussions under the National Health Act 1953. This could include administrative penalties or other enforcement actions deemed necessary by the Minister to ensure adherence to the HSD program's requirements. Given the nature of the Instrument and its role in regulating highly specialised drugs, strict compliance is expected, and any breaches could potentially impact the availability and prescription of these critical pharmaceutical items.
Furthermore, the Instrument allows for the variation or revocation of the special arrangement by the Minister, as provided in subsection 100(2) of the National Health Act 1953. This provision ensures that the Minister has the flexibility to adapt the HSD program in response to changing medical needs, new pharmaceutical developments, and recommendations from expert bodies like the Pharmaceutical Benefits Advisory Committee (PBAC). The ongoing consultation process with PBAC and other stakeholders ensures that the amendments reflect the latest medical and economic evidence, balancing the need for access to innovative treatments with the responsible use of public funds.